Condition category
Cancer
Date applied
30/01/2014
Date assigned
30/01/2014
Last edited
27/06/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Janet Horsman

ORCID ID

Contact details

Department of Clinical Oncology
Weston Park Hospital
Whitham Road
Sheffield
S10 2SJ
United Kingdom
J.M.Horsman@sheffield.ac.uk

Additional identifiers

EudraCT number

2013-002505-62

ClinicalTrials.gov number

Protocol/serial number

15852

Study information

Scientific title

Acronym

SarCaBon: Saracatinib versus placebo for cancer-induced bone pain

Study hypothesis

The aim of this randomised double-blind phase II trial is to determine whether Saracatinib has clinical efficacy as an analgesic for bone pain that is due to bone metastases in cancer patients by comparing patients' self-reported pain ratings after 4 weeks on treatment, with pain scores from patients who receive placebo

Ethics approval

13/YH/0263; First MREC approval date 24/10/2013

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: National Cancer Research Network; Subtopic: All Cancers/Misc Sites; Disease: All

Intervention

Saracatanib/Placebo, Saracatinib at 125mg per day or placebo for 28 days

Intervention type

Drug

Phase

Phase II

Drug names

Saracatinib

Primary outcome measures

Pain score: Whether patientsÂ’ self-reported pain scores are significantly lower after 4 weeks on treatment with

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/02/2014

Overall trial end date

01/02/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Able to give written informed consent and willing to follow the study protocol
2. Age = 16 years
3. Cytologically or histologically confirmed solid tumours of known primary site with painful bone metastases and poor control of bone pain
4. WHO performance status = 2
5. Average baseline pain score = 4 and = 9 on 10 numerical scale recorded over at least two separate days
6. Adequate baseline haematological, hepatic and renal function, defined as follows:
Absolute neutrophil count = 1.5 x 109/L, Haemoglobin >9.0 g/dL (can be after transfusion), Platelet count = 100 x 109/L, Bilirubin = 1.5 x ULN, ALT or AST = 2.5 x ULN (= 5 x ULN if liver metastases), Creatinine = 1.5 x ULN
7. Ability to take and absorb oral medications
8. Female patients of childbearing potential (i.e. premenopausal females, females who have been menopausal for < 1 year and not surgically sterilized) must provide a negative pregnancy test (serum) = 7 days before study treatment begins and must agree to practice effective contraceptive measures (oral contraceptive pill, intrauterine device or diaphragm with spemicide) plus condoms during the study and for 30 days after last dose of saracatinib
9. Male patients with a partner of childbearing potential (who is not using an acceptable highly effective method of contraception) or a pregnant partner must use effective contraceptive measures (see 8) plus condoms during the study and for 3 months after the last dose of saracatinib. Patients should abstain from sperm donation during the study and for 3 months after the last dose of saracatinib

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 62; UK Sample Size: 62

Participant exclusion criteria

1. Life expectancy less than 3 months
2. Previous or planned radiotherapy at site of pain
3. Unstable cardiac disease in last 3 months
4. History of interstitial lung disease (bilateral, diffuse parenchymal lung disease) in view of known saracatinib-related pneumonitis
5. Unable to discontinue any medication with known moderate or potent inhibitory effect on CYP3A4, or is a substrate of CYP3A4
6. Concomitant cytotoxic chemotherapy unless established on maintenance treatment for > 6 weeks (not in a clinical trial)
7. Unable to understand written or spoken English as the primary outcome is dependent on completion of the BPISF questionnaire

Recruitment start date

01/02/2014

Recruitment end date

01/02/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Clinical Oncology
Sheffield
S10 2SJ
United Kingdom

Sponsor information

Organisation

Sheffield Teaching Hospitals NHS Trust (UK)

Sponsor details

Research Department
11 Broomfield Road
Sheffield
S10 2SE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes